Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)

A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

Study Overview

• Status: Completed
• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Study Type: Observational
• Enrollment (Actual): 3409

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425APQ
    • Otsuka Investigational Site
  • Buenos Aires, Argentina, C1181ACH
    • Otsuka Investigational Site
  • Ciudad de Buenos Aires, Argentina, C1155AHD
    • Otsuka Investigational Site
  • Ciudad de Buenos Aires, Argentina, C1431FWO
    • Otsuka Investigational Site
  • Córdoba, Argentina, X5016KEH
    • Otsuka Investigational Site
  • Córdoba, Argentina, X5002HWE
    • Otsuka Investigational Site
  • Sante Fe, Argentina, 3000
    • Otsuka Investigational Site
  • Buenos Aires
    • Avellaneda, Buenos Aires, Argentina, 1872
      • Otsuka Investigational Site
    • Junín, Buenos Aires, Argentina, 6000
      • Otsuka Investigational Site
    • La Plata, Buenos Aires, Argentina, B1902AWL
      • Otsuka Investigational Site
    • Pergamino, Buenos Aires, Argentina, 2700
      • Otsuka Investigational Sites
    • Pilar, Buenos Aires, Argentina, B16260DT
      • Otsuka Investigational Site
  • C.a.b.a.
    • Buenos Aires, C.a.b.a., Argentina, C1429BWN
      • Otsuka Investigational Site
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Otsuka Investigational Site
    • Newcastle, New South Wales, Australia, 2305
      • Otsuka Investigational Site
    • Sydney, New South Wales, Australia, 2031
      • Otsuka Investigational Site
    • Sydney, New South Wales, Australia, 2050
      • Otsuka Investigational Site
    • Sydney, New South Wales, Australia, 2065
      • Otsuka Investigational Site
    • Sydney, New South Wales, Australia, 2139
      • Otsuka Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • Otsuka Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Otsuka Investigational Site
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Otsuka Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Otsuka Investigational Site
    • Melbourne, Victoria, Australia, 3073
      • Otsuka Investigational Site
    • Parkville, Victoria, Australia, 3050
      • Otsuka Investigational Site
    • Richmond, Victoria, Australia, 3121
      • Otsuka Investigational Site
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Otsuka Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • Otsuka Investigational Site
  • Ghent, Belgium, 9000
    • Otsuka Investigational Site
  • Leuven, Belgium, 3000
    • Otsuka Investigational Site
• Brazil
  • São Paulo, Brazil, 04038-002
    • Otsuka Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30180-060
      • Otsuka Investigational Site
    • Juiz de Fora, Minas Gerais, Brazil, 36036-330
      • Otsuka Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-020
      • Otsuka Investigational Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Otsuka Investigational Site
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Otsuka Investigational Site
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Otsuka Investigational Site
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89227-680
      • Otsuka Investigational Site
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15015-200
      • Otsuka Investigational Site
    • São Paulo, São Paulo, Brazil, 01246-903
      • Otsuka Investigational Site
    • São Paulo, São Paulo, Brazil, 01323-001
      • Otsuka Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Otsuka Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 1Y2
      • Otsuka Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Otsuka Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Otsuka Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Otsuka Investigational Site
    • Edmonton, Ontario, Canada, T6G2B7
      • Otsuka Investigational Site
    • Oakville, Ontario, Canada, L6J 3M5
      • Otsuka Investigational Site
    • Scarborough Village, Ontario, Canada, M1H 3G4
      • Otsuka Investigational Site
    • Toronto, Ontario, Canada, M4C 5T2
      • Otsuka Investigational Site
    • Toronto, Ontario, Canada, M5B 1W8
      • Otsuka Investigational Site
    • Toronto, Ontario, Canada, M5G 2N2
      • Otsuka Investigational Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Otsuka Investigational Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Otsuka Investigational Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Otsuka Investigational Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Otsuka Investigational Site
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Otsuka Investigational Site
  • Jihlava, Czechia, 586 33
    • Otsuka Investigational Site
  • Liberec, Czechia, 460 63
    • Otsuka Investigational Site
  • Prague, Czechia, 128 08
    • Otsuka Investigational Site
  • České Budějovice, Czechia, 370 01
    • Otsuka Investigational Site
• France
  • Caen, France, 14033
    • Otsuka Investigational Site
  • Grenoble, France, 38043
    • Otsuka Investigational Site
  • Lyon, France, 69437
    • Otuska Investigational Site
  • Lyon, France, 69473
    • Otsuka Investigational Site
  • Montpellier, France, 34295
    • Otsuka Investigational Site
  • Pierre-Bénite, France, 69495
    • Otsuka Investigational Site
  • Vandœuvre-lès-Nancy, France, 54511
    • Otsuka Investigational Site
• Germany
  • Berlin, Germany, 10117
    • Otsuka Investigational Site
  • Dresden, Germany, 01307
    • Otsuka Investigational Site
  • Düsseldorf, Germany, 40210
    • Otsuka Investigational Site
  • Erlangen, Germany, 91054
    • Otsuka Investigational Site
  • Hanover, Germany, 30625
    • Otsuka Investigational Site
  • Heidelberg, Germany, 69120
    • Otsuka Investigational Site
  • Munich, Germany, 81675
    • Otsuka Investigational Site
  • Wiesbaden, Germany, 65191
    • Otsuka Investigational Site
• Italy
  • Bologna, Italy, 40138
    • Otsuka Investigational Site
  • Lecco, Italy, 23900
    • Otsuka Investigational Site
  • Modena, Italy, 41100
    • Otsuka Investigational Site
  • Montichiari, Italy, 25018
    • Otsuka Investigational Site
  • Naples, Italy, 80131
    • Otsuka Investigational Site
  • Pavia, Italy, 27100
    • Otsuka Investigational Site
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Otsuka Investigational Site
• Japan
  • Chiba, Japan, 260-8712
    • Otsuka Investigational Site
  • Fukuoka, Japan, 812-8582
    • Otsuka Investigational Site
  • Hokkaido, Japan, 060-8638
    • Otsuka Investigational Site
  • Niigata, Japan, 951-8520
    • Otsuka Investigational Site
  • Osaka, Japan, 545-8586
    • Otsuka Investigational Site
  • Osaka, Japan, 565-0871
    • Otsuka Investigational Site
  • Tochigi, Japan, 329-0498
    • Otsuka Investigational Site
  • Tokyo, Japan, 113-8510
    • Otsuka Investigational Site
  • Tokyo, Japan, 113-8603
    • Otsuka Investigational Site
  • Tokyo, Japan, 162-8666
    • Otsuka Investigational Site
  • Tokyo, Japan, 173-8606
    • Otsuka Investigational Site
  • Tokyo, Japan, 181-8611
    • Otsuka Investigational Site
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Otsuka Investigational Site
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 701-0192
      • Otsuka Investigational Site
• Netherlands
  • Groningen, Netherlands, 9700RB
    • Otsuka Investigational Site
  • Leiden, Netherlands, 2333 ZA
    • Otsuka Investigational Site
  • Nijmegen, Netherlands, 6525 GA
    • Otsuka Investigational Site
  • Rotterdam, Netherlands, 3015 CE
    • Otsuka Investigational Site
• Norway
  • Drammen, Norway, 3004
    • Otsuka Investigational Site
  • Lillehammer, Norway, 2609
    • Otsuka Investigational Site
• Poland
  • Ciechanów, Poland, 06-400
    • Otsuka Investigational Site
  • Golub-Dobrzyń, Poland, 87-400
    • Otsuka Investigational Site
  • Krakow, Poland, 30-663
    • Otsuka Investigational Site
  • Lodz, Poland, 93-338
    • Otsuka Investigational Site
  • Radom, Poland, 26-610
    • Otsuka Investigational Site
  • Rzeszów, Poland, 35-055
    • Otsuka Investigational Site
  • Szczecin, Poland, 70-111
    • Otsuka Investigational Site
  • Warsaw, Poland, 04-730
    • Otsuka Investigational Site
  • Warsaw, Poland, 04-749
    • Otsuka Investigational Site
  • Wroclaw, Poland, 50-556
    • Otsuka Investigational Site
• Romania
  • Bucharest, Romania, 010731
    • Otsuka Investigational Site
  • Bucharest, Romania, 022328
    • Otsuka Investigational Site
  • Bihor County
    • Oradea, Bihor County, Romania, 410469
      • Otsuka Investigational Site
  • Timiș County
    • Timișoara, Timiș County, Romania, 300736
      • Otsuka Investigational Site
• Spain
  • Alicante, Spain, 03010
    • Otsuka Investigational Site
  • Barcelona, Spain, 08036
    • Otsuka Investigational Site
  • Ciudad Real, Spain, 13005
    • Otsuka Investigational Site
  • Hospitalet de Ilobre, Spain, 08907
    • Otsuka Investigational Site
  • Madrid, Spain, 28046
    • Otsuka Investigational Site
• Sweden
  • Malmo, Sweden, 20502
    • Otsuka Investigational Site
  • Stockholm, Sweden, 14186
    • Otsuka Investigational Site
• Switzerland
  • Zurich, Switzerland, 8091
    • Otsuka Investigational Site
• Turkey (Türkiye)
  • Balcali-Adana, Turkey (Türkiye), 1330
    • Otsuka Investigational Site
  • Bornova-Izmir, Turkey (Türkiye), 35100
    • Otsuka Investigational Site
  • Izmir, Turkey (Türkiye), 35100
    • Otsuka Investigational Site
  • Sihhiye-Ankara, Turkey (Türkiye), 6100
    • Otsuka Investigational Site
  • Capa
    • Istanbul, Capa, Turkey (Türkiye), 34390
      • Otsuka Investigational Site
  • İzmir
    • Inciraltı, İzmir, Turkey (Türkiye), 35340
      • Otsuka Investigational Site
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Otsuka Investigational Site
  • Bradford, United Kingdom, BD5 0NA
    • Otsuka Investigational Site
  • Bristol, United Kingdom, BS2 8BJ
    • Otsuka Investigational Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Otsuka Investigational Site
  • Chelmsford, United Kingdom, CM1 7ET
    • Otsuka Investigational Site
  • Coventry, United Kingdom, CV2 2DX
    • Otsuka Investigational Site
  • Dorchester, United Kingdom, DT1 2JY
    • Otsuka Investigational Site
  • Edinburgh, United Kingdom, EH16 4SA
    • Otsuka Investigational Site
  • Hull, United Kingdom, HU3 2JZ
    • Otsuka Investigational Site
  • Inverness, United Kingdom, IV2 3UJ
    • Otsuka Investigational Site
  • Kirkcaldy, United Kingdom, KY2 5AH
    • Otsuka Investigational Site
  • Leicester, United Kingdom, LE5 4PW
    • Otsuka Investigational Site
  • Liverpool, United Kingdom, L7 8XP
    • Otsuka Investigational Site
  • London, United Kingdom, NW3 2QG
    • Otsuka Investigational Site
  • London, United Kingdom, SW17 0QT
    • Otsuka Investigational Site
  • London, United Kingdom, WC1N 3JH
    • Otsuka Investigational Site
  • Manchester, United Kingdom, M13 9WL
    • Otsuka Investigational Site
  • Middlesbrough, United Kingdom, TS4 3BW
    • Otsuka Investigational Site
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Otsuka Investigational Site
  • Oxford, United Kingdom, OX3 7LJ
    • Otsuka Investigational Site
  • Portsmouth, United Kingdom, PO6 3LY
    • Otsuka Investigational Site
  • Preston, United Kingdom, PR2 9HT
    • Otsuka Investigational Site
  • Salford, United Kingdom, M6 8HD
    • Otsuka Investigational Site
  • Sheffield, United Kingdom, S5 7AU
    • Otsuka Investigational Site
  • Southampton, United Kingdom, SO16 6YD
    • Otsuka Investigational Site
  • Stevenage, United Kingdom, SG1 4AB
    • Otsuka Investigational Site
  • Westcliff-on-Sea, United Kingdom, SS0 0RY
    • Otsuka Investigational Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Otsuka Investigational Site
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Otsuka Investigational Site
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO31 8HE
      • Otsuka Investigational Site
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Otsuka Investigational Site
  • Surrey
    • Carshalton, Surrey, United Kingdom, SM5 1AA
      • Otsuka Investigational Site
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 6NH
      • Otsuka Investigational Site
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Otsuka Investigational Site 1
    • Peoria, Arizona, United States, 85381
      • Otsuka Investigational Site 2
    • Tempe, Arizona, United States, 85284
      • Otsuka Investigational Site
  • California
    • Azusa, California, United States, 91702
      • Otsuka Investigational Site
    • Bakersfield, California, United States, 93308
      • Otsuka Investigational Site
    • Los Angeles, California, United States, 90025
      • Otsuka Investigational Site
    • Los Angeles, California, United States, 90022
      • Otsuka Investigational Site
    • Ontario, California, United States, 91762
      • Otsuka Investigational Site
    • San Diego, California, United States, 92108
      • Otsuka Investigational Site
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Otsuka Investigational Site
    • Aurora, Colorado, United States, 80045
      • Otsuka Investigational Site
    • Denver, Colorado, United States, 80210
      • Otsuka Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Otsuka Investigational Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Otsuka Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Otsuka Investigational Site
    • Hudson, Florida, United States, 34667
      • Otsuka Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Otsuka Investigational Site
    • Melbourne, Florida, United States, 32935
      • Otsuka Investigational Site
    • Port Charlotte, Florida, United States, 33952
      • Otsuka Investigational Site
    • Tampa, Florida, United States, 33614
      • Otsuka Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Otsuka Investigational Site
    • Augusta, Georgia, United States, 30901
      • Otsuka Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Otsuka Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Otsuka Investigational Site
    • Peoria, Illinois, United States, 61602
      • Otsuka Investigational Site
  • Indiana
    • Mishawaka, Indiana, United States, 46545
      • Otsuka Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66106
      • Otsuka Investigational Site
    • Wichita, Kansas, United States, 67214
      • Otsuka Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Otsuka Investigational Site
    • Paducah, Kentucky, United States, 42003
      • Otsuka Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Otsuka Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Otsuka Investigational Site
    • Baltimore, Maryland, United States, 21201
      • Otsuka Investigational Site
    • Bethesda, Maryland, United States, 20814
      • Otsuka Investigational Site
    • Rockville, Maryland, United States, 20850
      • Otsuka Investigational Site
    • Rockville, Maryland, United States, 20852
      • Otsuka Investigational Site
    • Wheaton, Maryland, United States, 20906
      • Otsuka Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Otsuka Investigational Site
    • Boston, Massachusetts, United States, 02215
      • Otsuka Investigational Site
    • Holyoke, Massachusetts, United States, 01040
      • Otuska Investigational Site
    • Plymouth, Massachusetts, United States, 02360
      • Otsuka Investigational Site
    • Springfield, Massachusetts, United States, 01107
      • Otsuka Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Otsuka Investigational Site
    • Kalamazoo, Michigan, United States, 49007
      • Otsuka Investigational Site
    • Pontiac, Michigan, United States, 48341
      • Otsuka Investigational Site
    • Royal Oak, Michigan, United States, 48073
      • Otsuka Investigational Site
  • Minnesota
    • Brooklyn Center, Minnesota, United States, 55430
      • Otsuka Investigational Site
    • Rochester, Minnesota, United States, 55905
      • Otsuka Investigational Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Otsuka Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Otsuka Investigational Site
    • Las Vegas, Nevada, United States, 89115
      • Otsuka Investigational Site
    • Reno, Nevada, United States, 89511
      • Otsuka Investigational Site
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Otsuka Investigational Site
    • Princeton Junction, New Jersey, United States, 08550
      • Otsuka Investigational Site
    • Voorhees Township, New Jersey, United States, 08043
      • Otsuka Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Otsuka Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • Otsuka Investigational Site
    • Brooklyn, New York, United States, 11215
      • Otsuka Investigational Site
    • Buffalo, New York, United States, 14215
      • Otsuka Investigational Site
    • Flushing, New York, United States, 11355
      • Otsuka Investigational Site
    • Forest Hills, New York, United States, 11375
      • Otsuka Investigational Site
    • Great Neck, New York, United States, 11021
      • Otsuka Investigational Site
    • Mineola, New York, United States, 11501
      • Otsuka Investigational Site
    • New York, New York, United States, 10016
      • Otsuka Investigational Site
    • New York, New York, United States, 10021
      • Otsuka Investigational Site
    • New York, New York, United States, 10033
      • Otsuka Investigational Site
    • Port Washington, New York, United States, 11050
      • Otsuka Investigational Site
    • Rochester, New York, United States, 14642
      • Otsuka Investigational Site
    • Rosedale, New York, United States, 11422
      • Otsuka Investigational Site
    • The Bronx, New York, United States, 10467
      • Otsuka Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Otsuka Investigational Site
    • Durham, North Carolina, United States, 27705
      • Otsuka Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Otsuka Investigational Site
  • North Dakota
    • Devils Lake, North Dakota, United States, 58301
      • Otsuka Investigational Site
    • Fargo, North Dakota, United States, 58122
      • Otsuka Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Otsuka Investigational Site
    • Cleveland, Ohio, United States, 44106
      • Otsuka Investigational Site
    • Columbus, Ohio, United States, 43210
      • Otsuka Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Otsuka Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Otsuka Investigational Site
    • Bethlehem, Pennsylvania, United States, 18017
      • Otsuka Investigational Site
    • Doylestown, Pennsylvania, United States, 18901
      • Otsuka Investigational Site
    • Lancaster, Pennsylvania, United States, 17604
      • Otsuka Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Otsuka Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Otsuka Investigational Site
  • South Carolina
    • Aiken, South Carolina, United States, 29801
      • Otsuka Investigational Site
    • Anderson, South Carolina, United States, 29621
      • Otsuka Investigational Site
    • Columbia, South Carolina, United States, 29203
      • Otsuka Investigational Site
    • Columbia, South Carolina, United States, 29209
      • Otsuka Investigational Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Otsuka Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Otsuka Investigational Site
  • Texas
    • Arlington, Texas, United States, 76015
      • Otsuka Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Otsuka Investigational Site
    • Houston, Texas, United States, 77004
      • Otsuka Investigational Site
    • Houston, Texas, United States, 77030
      • Otsuka Investigational Site
    • Mission, Texas, United States, 78572
      • Otsuka Investigational Site
    • San Antonio, Texas, United States, 78215
      • Otsuka Investigational Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Otsuka Investigational Site
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • Otsuka Investigational Site
  • West Virginia
    • Bluefield, West Virginia, United States, 24701
      • Otsuka Investigational Site
    • Morgantown, West Virginia, United States, 26506
      • Otsuka Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53713
      • Otsuka Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.

Description

Inclusion Criteria:

• existing diagnosis of ADPKD by modified-Ravine criteria
• Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

Exclusion Criteria:

• Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of change in total kidney volume with ADPKD-related outcomes	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient-reported pain	every 6 months
SF-12 Scores	every 6 months
ADPKD-Impact Scale Score	every 6 months
Cost of care	every 6 months
EQ-5D Scores	Every 6 months

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Gitomer BY, Chonchol M, Zhou X, Garbinsky D, Wang J, Nunna S, Fernandes AW, Oberdhan D. Kidney Stone Disease and Progression Risk in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis of OVERTURE. Kidney360. 2024 Sep 1;5(9):1364-1366. doi: 10.34067/KID.0000000000000524. Epub 2024 Jul 24. No abstract available.
• Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Nephrol. 2023 Jun 22;24(1):182. doi: 10.1186/s12882-023-03247-6.
• Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun.
• Perrone RD, Oberdhan D, Ouyang J, Bichet DG, Budde K, Chapman AB, Gitomer BY, Horie S, Ong ACM, Torres VE, Turner AN, Krasa H. OVERTURE: A Worldwide, Prospective, Observational Study of Disease Characteristics in Patients With ADPKD. Kidney Int Rep. 2023 Feb 13;8(5):989-1001. doi: 10.1016/j.ekir.2023.02.1073. eCollection 2023 May.

Helpful Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 29, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimated): September 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: 156-10-291